NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

The Psychobiology of Temperament: An fMRI Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

03-M-0186

Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 mo
Max Age: 60 Years

Referral Letter Required

Yes

Population Exclusion(s)

Fetuses;
Pregnant Women

Keywords

Magnetic Resonance Imaging;
Adolescence;
Emotion;
Behavioral Inhibition;
Depression;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Developmental Psychology

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Mental HealthUniversity of Maryland, College Park

The purpose of this study is to use brain imaging technology to examine brain changes that occur in children when they are exposed to various kinds of emotional tasks and to determine if these changes are related to the child's temperament.

Studies suggest that the risk for developing mood and anxiety disorders in preschool children may be linked to differences in temperament. The relationship between temperament and risk or resilience may reflect the influences of brain activity on behavior at different stages of childhood development. Behavioral inhibition and mood or anxiety disorders have been linked to disturbances in the circuitry of several areas in the brain. However, the involvement of this circuitry in temperament remains unclear. This study will use functional magnetic resonance imaging (fMRI) to examine the function of different parts of the brain in children who have previously undergone temperament studies and have had their temperaments classified.

Two sets of studies will be performed in the current protocol. A small set of pilot studies will be performed in infants, by staff at the University of Maryland. In terms of the studies among infants, these subjects will initially be contacted by staff at Maryland and then will be seen at the NIH for up to three visits lasting between 4- to 5- hours during the first year of life. These subjects also will undergo visits at the University of Maryland throughout the first year of life.

This study will comprise up to four clinic visits. At Visit 1, children and their parents will meet with study staff individually and together for psychiatric interviews. Children will undergo a physical examination, medical history, a urine drug test, and practice in an fMRI simulator. Saliva samples will be collected from the children and tests will be given to assess stage of puberty, temperament, intelligence, feelings, experiences, and behavior. Other visits include fMRI scans of the brain and other tasks.

--Back to Top--

Eligibility

INCLUSION CRITERIA:

-Consent: Can give consent/assent.

-Age: 2 months-14 months; 7-60 years

-Children in Cohort 4: Age: 9-11 years

-IQ: All subjects will have IQ greater than 70. (exception: infants will not need to meet this criteria)

-Psychopathology: all subjects will be free of lifetime history of psychosis and pervasive developmental disorder

-Specific to infant cohort: between the ages of 4 and 14 months of age and is free of any known developmental disability or medical condition

EXCLUSION CRITERIA:

-Any chronic or acute medical condition severe enough to interfere with task performance or completion of questionnaires; Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye, dental braces)

-Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye, dental braces).

-Any current axis I psychiatric disorder necessitating acute treatment.

-Claustrophobia

-Pregnancy

-Specific to infant cohort:

1) Was born prematurely, before 36 weeks gestation

2) Had a birth weight significantly below normal for gestational age

3) Has any known developmental disability or medical condition

4) Has any metallic objects in their body (e.g., Has implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), implanted delivery pump,

5) Comes from a home where the primary language spoken is not English

-NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Daniel S. Pine, M.D.
National Institute of Mental Health (NIMH)
NIHBC 15K - QUARTERS BG RM 110
15K NORTH DR
BETHESDA MD 20892
(301) 594-1318
daniel.pine@nih.gov

Daniel S. Pine, M.D.
National Institute of Mental Health (NIMH)
NIHBC 15K - QUARTERS BG RM 110
15K NORTH DR
BETHESDA MD 20892
(301) 594-1318
daniel.pine@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00060775

--Back to Top--